BR112017016410B1 - Dispositivo de inspeção para testar a integridade de um recipiente preenchido com fármaco e método para testar um fechamento de recipiente em relação à integridade utilizando um dispositivo de inspeção - Google Patents

Dispositivo de inspeção para testar a integridade de um recipiente preenchido com fármaco e método para testar um fechamento de recipiente em relação à integridade utilizando um dispositivo de inspeção Download PDF

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Publication number
BR112017016410B1
BR112017016410B1 BR112017016410-8A BR112017016410A BR112017016410B1 BR 112017016410 B1 BR112017016410 B1 BR 112017016410B1 BR 112017016410 A BR112017016410 A BR 112017016410A BR 112017016410 B1 BR112017016410 B1 BR 112017016410B1
Authority
BR
Brazil
Prior art keywords
light source
inspection device
container
viewing
sample container
Prior art date
Application number
BR112017016410-8A
Other languages
English (en)
Portuguese (pt)
Other versions
BR112017016410A2 (pt
Inventor
Steve Angermund
George Currier
Joe Jy Koo
Original Assignee
Bristol-Myers Squibb Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Application filed by Bristol-Myers Squibb Company filed Critical Bristol-Myers Squibb Company
Publication of BR112017016410A2 publication Critical patent/BR112017016410A2/pt
Publication of BR112017016410B1 publication Critical patent/BR112017016410B1/pt

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    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/90Investigating the presence of flaws or contamination in a container or its contents
    • G01N21/9054Inspection of sealing surface and container finish
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00Investigating fluid-tightness of structures
    • G01M3/02Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/20Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material
    • G01M3/22Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/226Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators
    • G01M3/229Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators removably mounted in a test cell
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01MTESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00Investigating fluid-tightness of structures
    • G01M3/38Investigating fluid-tightness of structures by using light
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64Fluorescence; Phosphorescence
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/8803Visual inspection
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/8806Specially adapted optical and illumination features
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/90Investigating the presence of flaws or contamination in a container or its contents
    • G01N21/9018Dirt detection in containers
    • G01N21/9027Dirt detection in containers in containers after filling
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84Systems specially adapted for particular applications
    • G01N21/88Investigating the presence of flaws or contamination
    • G01N21/91Investigating the presence of flaws or contamination using penetration of dyes, e.g. fluorescent ink
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L9/00Supporting devices; Holding devices
    • B01L9/06Test-tube stands; Test-tube holders
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00Features of devices classified in G01N21/00
    • G01N2201/06Illumination; Optics
    • G01N2201/062LED's
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00Features of devices classified in G01N21/00
    • G01N2201/06Illumination; Optics
    • G01N2201/063Illuminating optical parts
    • G01N2201/0638Refractive parts

Landscapes

  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Investigating, Analyzing Materials By Fluorescence Or Luminescence (AREA)
  • Investigating Materials By The Use Of Optical Means Adapted For Particular Applications (AREA)
  • Examining Or Testing Airtightness (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
BR112017016410-8A 2015-02-23 2016-02-17 Dispositivo de inspeção para testar a integridade de um recipiente preenchido com fármaco e método para testar um fechamento de recipiente em relação à integridade utilizando um dispositivo de inspeção BR112017016410B1 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562119589P 2015-02-23 2015-02-23
US62/119,589 2015-02-23
PCT/US2016/018173 WO2016137789A1 (en) 2015-02-23 2016-02-17 Device and method for testing and inspecting integrity of a container

Publications (2)

Publication Number Publication Date
BR112017016410A2 BR112017016410A2 (pt) 2018-03-27
BR112017016410B1 true BR112017016410B1 (pt) 2022-01-04

Family

ID=55447152

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017016410-8A BR112017016410B1 (pt) 2015-02-23 2016-02-17 Dispositivo de inspeção para testar a integridade de um recipiente preenchido com fármaco e método para testar um fechamento de recipiente em relação à integridade utilizando um dispositivo de inspeção

Country Status (10)

Country Link
US (1) US10261030B2 (ru)
EP (1) EP3262400B1 (ru)
JP (1) JP6657238B2 (ru)
CN (1) CN107257921A (ru)
BR (1) BR112017016410B1 (ru)
CA (1) CA2977047C (ru)
EA (1) EA034400B1 (ru)
ES (1) ES2864762T3 (ru)
MX (1) MX2017010543A (ru)
WO (1) WO2016137789A1 (ru)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3681571B1 (en) * 2017-09-14 2022-01-19 Lonza Ltd Device and method for improved closure integrity testing
WO2020112875A1 (en) * 2018-11-30 2020-06-04 Genentech, Inc. Vial inspection method and apparatus
US11353403B2 (en) 2018-11-30 2022-06-07 Genentech, Inc. Vial contents inspection and material identification method and apparatus
JP2023505428A (ja) * 2020-01-17 2023-02-09 ガルシア、ローラ ロドリゲス 液体医薬品の品質を特定するための方法
EP3855174B1 (en) * 2020-01-23 2024-05-15 SCHOTT Pharma Schweiz AG Detection and characterization of defects in pharmaceutical cylindrical containers
CN111896192B (zh) * 2020-08-12 2022-11-11 重庆华邦制药有限公司 一种色水法测定包装密封性的测试方法

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US1521648A (en) * 1924-01-26 1925-01-06 Pickett James Display device
US2206728A (en) * 1939-10-20 1940-07-02 Nevins Church Press Display stand
US2479743A (en) 1947-04-24 1949-08-23 Flemmon P Hall Leak indicator for sealed receptacles
US2917183A (en) * 1954-02-08 1959-12-15 Arthur T Seelye Holder for test tubes
US3199684A (en) * 1964-07-06 1965-08-10 Bradley Rex Lee Adjustable test tube racks
DE1573413B2 (de) * 1965-03-09 1971-02-11 Brevetti CEA SpA, Vicenza (Italien) Einrichtung zur Kontrolle von in Am pullen oder anderen durchsichtigen, roh renformigen Behaltern enthaltenen Verun reinigungen
US3751172A (en) * 1972-03-24 1973-08-07 Baxter Laboratories Inc Viewing rack
US4363551A (en) * 1976-06-01 1982-12-14 Baxter Travenol Laboratories, Inc. Nephelometer having means semiautomatically canceling components from scattering by particles smaller or larger than those of interest
US4273416A (en) * 1979-01-02 1981-06-16 Blum Alvin S Indicating test tube rack
US4278176A (en) * 1979-07-02 1981-07-14 University Of Utah Gradient tube rack and method
US4349510A (en) * 1979-07-24 1982-09-14 Seppo Kolehmainen Method and apparatus for measurement of samples by luminescence
US4382679A (en) * 1980-10-06 1983-05-10 Cutter Laboratories, Inc. Dye leak detection method
US4748125A (en) * 1986-09-25 1988-05-31 Pizzolante John M Disposable adhesive test tube rack
US4947996A (en) * 1988-05-09 1990-08-14 Harris Howard J Unitary article holder/display
US4962041A (en) * 1988-10-06 1990-10-09 Medical Automation Specialities, Inc. Method and apparatus for automatic processing and analyzing of blood serum
US5632388A (en) * 1995-01-30 1997-05-27 Forma Scientific, Inc. Test tube rack assembly
JP2000245500A (ja) * 1998-12-28 2000-09-12 Kikkoman Corp 発光による試料の測定方法及び装置
US6646741B1 (en) * 2002-05-24 2003-11-11 Spectrex Corporation Method and apparatus for visualizing particles suspended in a fluid
US20050095717A1 (en) * 2003-10-31 2005-05-05 Wollenberg Robert H. High throughput screening methods for lubricating oil compositions
JP3908744B2 (ja) * 2004-03-08 2007-04-25 株式会社アイディエス 試験管のバーコード読取り装置
US8789713B2 (en) * 2012-07-23 2014-07-29 Charles Koller Surgical instrument caddy
US9907727B2 (en) * 2012-10-30 2018-03-06 Gary L. Sharpe Vial gripper
US9545634B2 (en) * 2012-11-20 2017-01-17 Tripath Imaging, Inc. Offset sample tube holder

Also Published As

Publication number Publication date
EA201791888A1 (ru) 2017-12-29
EP3262400A1 (en) 2018-01-03
EP3262400B1 (en) 2021-03-24
BR112017016410A2 (pt) 2018-03-27
CN107257921A (zh) 2017-10-17
MX2017010543A (es) 2017-12-14
CA2977047C (en) 2023-03-21
JP2018509606A (ja) 2018-04-05
CA2977047A1 (en) 2016-09-01
US20180045653A1 (en) 2018-02-15
WO2016137789A1 (en) 2016-09-01
EA034400B1 (ru) 2020-02-04
US10261030B2 (en) 2019-04-16
ES2864762T3 (es) 2021-10-14
JP6657238B2 (ja) 2020-03-04

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B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B06A Patent application procedure suspended [chapter 6.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 17/02/2016, OBSERVADAS AS CONDICOES LEGAIS.